MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).Date of event - estimated date.Date of implant - estimated.Date of explant - estimated.The customer reported a general comment, so no device is available.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the surgical intervention.It was reported as a general comment that the number of mitral valve replacements after mitraclip implantations is increasing.No additional information was provided.

Manufacturer Narrative

The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The devices were not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.All available information was reviewed, and the reported surgical procedure and hospitalization were result of case specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

Initial reporter.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9090010
• MDR Text Key: 161694192
• Report Number: 2024168-2019-11933
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 10/23/2019; 11/07/2019
• Supplement Dates FDA Received: 11/02/2019; 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability